OBJECTIVES: IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech-sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A. MATERIALS AND METHODS: IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A. RESULTS: Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %-21 %), 13 % (8 %-18 %), and 12 % (7 %-17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism). CONCLUSION: This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone. NCT03148418.
- Reck, M.
- Dziadziuszko, R.
- Sugawara, S.
- Kao, S.
- Hochmair, M.
- Huemer, F.
- de Castro, G., Jr.
- Havel, L.
- Bernabé Caro, R.
- Losonczy, G.
- Lee, J. S.
- Kowalski, D. M.
- Andric, Z.
- Califano, R.
- Veatch, A.
- Gerstner, G.
- Batus, M.
- Morris, S.
- Kaul, M.
- Cuchelkar, V.
- Li, H.
- Danner, B. J.
- Nabet, B. Y.
- Liu, S. V.
Keywords
- Atezolizumab
- Carboplatin
- Clinical Trial
- Drug Therapy
- Etoposide
- Immune Checkpoint Inhibitor
- Small Cell Lung Carcinoma
- Survival